Operating Instructions

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Electromagnetic Compatibility

The use of cables other than those specified or sold by Autonomic Technologies may result in

increased emissions or decreased electrical immunity of the system. The RF transmitter within the

remote controller operates at 126 kHz +/- 3kHz, with Frequency Shift Keying (FSK), and the effective

radiated power of less than 5mW. NOTE: The device remains safe under its typical electromagnetic

interference environment. The Pulsante® SPG Microstimulator System complies with the international

standard IEC 60601-1-2, Edition 4.0 2014-02 for Electromagnetic Compatibility (EMC). Use of this

equipment should follow the Electromagnetic Compatibility (EMC) guidance below.

GUIDANCE AND MANUFACTURER’S DECLARATION – ELECTROMAGNETIC EMISSIONS

The Pulsante® SPG Microstimulator System is intended for use in the electromagnetic environment specified below. The customer

or user of the Pulsante® SPG Microstimulator System should assure that it is used in such an environment.

EMMISSIONS/IMMUNITY TEST

TEST LEVEL

COMPLIANCE

LEVEL

ELECTROMAGNETIC

ENVIRONMENT

GUIDANCE

Radiated and Conducted emissions - CISPR 11

Pending test results

Harmonic emissions - IEC 61000-3-2

Pending test results

Voltage fluctuations / Flicker emissions - IEC 61000-3-3

Pending test results

Electrostatic discharge (ESD) - IEC 61000-4-2

Pending test results

Electrical fast - Transient burst - IEC 61000-4-4

Pending test results

Surge - IEC 61000-4-5

Pending test results

Voltage dips, short interruptions, and voltage variations on

power supply input lines - IEC 61000-4-11

Pending test results

Power frequency - 50/60 Hz magnetic field - IEC 61000-4-8

Pending test results

Conducted RF - IEC 61000-4-6

Pending test results

Radiated RF - IEC 61000-4-3

Pending test results

The Pulsante® SPG Microstimulator System is battery operated.

NOTE: The Pulsante® SPG Microstimulator System should not be used while stacked on or adjacent

to other equipment. If stacked use is necessary, the equipment should be observed to verify normal

operation in the configuration in which it will be used. Portable and mobile RF communications

equipment can affect the System; the following separation distances are recommended.

RECOMMENDED SEPARATION DISTANCES BETWEEN PORTABLE AND MOBILE RF

COMMUNICATIONS EQUIPENT AND THE PULSANTE® SPG MICROSTIMULATOR SYSTEM

The Pulsante® SPG Microstimulator System is intended for use in the electromagnetic environment in which radiated RF

disturbances are controlled. The customer or user of the Pulsante® SPG Microstimulator System can help prevent electromagnetic

interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the

Pulsante® SPG Microstimulator System as recommended below, according to the maximum output power of the communications

equipment.

Rated Maximum Output Power

of Transmitter (W)

Separation Distance According to Frequency of Transmitter (M)

150 KHz to 80 MHz

80 MHz to 800 MHz

800 MHz to 2.5 GHz

0.01

Pending test results

0.1

Pending test results

100

Pending test results

For transmitters rated at a maximum output power not listed above, the recommended separation distance is pending test results.

Specifications for the Pulsante® Microstimulator:

STIMULATION PARAMETER

SPECIFICATION

Power Source

Resonant Inductive Coupling Powered, no finite life

Channels

Six (6) Channels

PHYSICAL CHARACTERISTICS

SPECIFICATION

Sizes

Short, Medium, Long, Extra-Long

Body

Pending test results

Weight

Pending test results

Volume

Pending test results

Storage Temperature

Pending test results